Simcyp Consultancy Services

Consultancy and guidance on a broad spectrum of DMPK issues, including optimal design for metabolic drug-drug interaction studies, interpretation of data and prediction of in vivo ADME from in vitro studies.

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Decades of experience supporting model based drug development

Certara was formed by the acquisition of Tripos®, Pharsight®, Simcyp, and Synchrogenix, each with a primary focus on a key phase within the drug discovery and development cycle, to create a single company with a unique set of capabilities for modeling, analysis, and simulation that span early discovery through Phase IV clinical trials.

Tripos

Established in 1979, Tripos was the first company to bring computer aided, scientific computational drug discovery capabilities to the pharmaceutical industry, subsequently continuing to help a broad range of pharmaceutical companies and research facilities successfully accelerate the identification and optimization of new compounds that have the potential to become new products in the drug, chemical, research, food, flavoring and fragrance markets

Pharsight

Pharsight was formed in 1995 and is widely known for the WinNonlin PK/PD modeling and simulation software, originally developed in 1984, and now well established as the leading tool of its kind in the industry. Since then, Pharsight has developed a wide range of PK/PD and clinical trial modeling and simulation software that touches nearly every drug in development. Additionally, Pharsight Consulting Services is the world’s largest PK/PD consulting services team that supports regulatory compliant analysis and clinical study reports.

Simcyp

Simcyp Limited was founded in 2001 as a spin-out company from the University of Sheffield, UK. Through a pre-competitive consortium, Simcyp develops a user-friendly platform designed specifically to allow you to conduct simulations in representative virtual patient populations based on your in vitro and clinical data. The Simulator includes extensive demographic, physiologic and genomic databases which have allowed us to develop algorithms which account for patient variability. This enables the user to predict drug behavior in the virtual patient population, as opposed to a virtual reference man, allowing individuals at extreme risk to be identified.

Synchrogenix

Synchrogenix is a specialty contract research organization providing strategic regulatory writing and related services to pharmaceutical, biotechnology, and medical device companies worldwide. Formed in 1986, the company offers pre-clinical, clinical, CMC, and drug safety writing and submission services. All Synchrogenix writers are experienced regulatory writing experts with a thorough knowledge of regulatory documents and the drug development process. Synchrogenix’s cohesive writing group can maintain strategic messaging across functional areas, ensuring a document that reviewers will find complete, consistent, and readable. By making documents clear and accessible the first time, Synchrogenix reduces reviewers’ questions and concerns, expediting movement through regulatory processes.